SYMPHONY 1020-00-000SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034526799), received between Jul 5, 2022 and Aug 18, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Migration

  Patient problems: Insufficient Information

  MAUDE report 50308237 ↗
• InjuryJan 17, 2025Break; Break

  IT WAS REPORTED THAT ALMOST ALL INNER SCREWS FROM A SYMPHONY CONSTRUCTION DETACHED FROM THE HEAD OF THE SCREW. THE FIRST SURGERY WAS ON (B)(6) 2024 AND IN POST OP EXAM IT WAS VERIFIED THAT THAT CONSTRUCTION FAILED WITH THE LOOSE LOCKING SCREWS. ALMOST ALL PEDICLE SCREWS REMAINED ON PLACE. NON UNION WAS ALSO NOTED. THE PATIENT UNDERWENT REVISION SURGERY, WHICH WENT WELL.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21180760 ↗
• InjuryJan 17, 2025Break; Break

  IT WAS REPORTED THAT ALMOST ALL INNER SCREWS FROM A SYMPHONY CONSTRUCTION DETACHED FROM THE HEAD OF THE SCREW. THE FIRST SURGERY WAS ON (B)(6) 2024 AND IN POST OP EXAM IT WAS VERIFIED THAT THAT CONSTRUCTION FAILED WITH THE LOOSE LOCKING SCREWS. ALMOST ALL PEDICLE SCREWS REMAINED ON PLACE. NON UNION WAS ALSO NOTED. THE PATIENT UNDERWENT REVISION SURGERY, WHICH WENT WELL.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21180698 ↗
• InjuryJan 17, 2025Break; Break

  IT WAS REPORTED THAT ALMOST ALL INNER SCREWS FROM A SYMPHONY CONSTRUCTION DETACHED FROM THE HEAD OF THE SCREW. THE FIRST SURGERY WAS ON (B)(6) 2024 AND IN POST OP EXAM IT WAS VERIFIED THAT CONSTRUCTION FAILED WITH THE LOOSE LOCKING SCREWS. ALMOST ALL PEDICLE SCREWS REMAINED ON PLACE. NON-UNION WAS ALSO NOTED. THE PATIENT UNDERWENT REVISION SURGERY, WHICH WENT WELL.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21180685 ↗
• InjuryJan 17, 2025Break; Break

  IT WAS REPORTED THAT ALMOST ALL INNER SCREWS FROM A SYMPHONY CONSTRUCTION DETACHED FROM THE HEAD OF THE SCREW. THE FIRST SURGERY WAS ON (B)(6) 2024 AND IN POST OP EXAM IT WAS VERIFIED THAT CONSTRUCTION FAILED WITH THE LOOSE LOCKING SCREWS. ALMOST ALL PEDICLE SCREWS REMAINED ON PLACE. NON UNION WAS ALSO NOTED. THE PATIENT UNDERWENT REVISION SURGERY, WHICH WENT WELL.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21180670 ↗
• InjuryJan 17, 2025Break; Break

  IT WAS REPORTED THAT ALMOST ALL INNER SCREWS FROM A SYMPHONY CONSTRUCTION DETACHED FROM THE HEAD OF THE SCREW. THE FIRST SURGERY WAS ON (B)(6) 2024 AND IN POST OP EXAM IT WAS VERIFIED THAT CONSTRUCTION FAILED WITH THE LOOSE LOCKING SCREWS. ALMOST ALL PEDICLE SCREWS REMAINED ON PLACE. NON-UNION WAS ALSO NOTED. THE PATIENT UNDERWENT REVISION SURGERY, WHICH WENT WELL.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21180608 ↗
• InjuryJan 17, 2025Break; Break

  IT WAS REPORTED THAT ALMOST ALL INNER SCREWS FROM A SYMPHONY CONSTRUCTION DETACHED FROM THE HEAD OF THE SCREW. THE FIRST SURGERY WAS ON (B)(6) 2024 AND IN POST OP EXAM IT WAS VERIFIED THAT THAT CONSTRUCTION FAILED WITH THE LOOSE LOCKING SCREWS. ALMOST ALL PEDICLE SCREWS REMAINED ON PLACE. NON-UNION WAS ALSO NOTED. THE PATIENT UNDERWENT REVISION SURGERY, WHICH WENT WELL.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21180152 ↗
• InjuryJan 17, 2025Break; Break

  IT WAS REPORTED THAT ALMOST ALL INNER SCREWS FROM A SYMPHONY CONSTRUCTION DETACHED FROM THE HEAD OF THE SCREW. THE FIRST SURGERY WAS ON (B)(6) 2024 AND IN POST OP EXAM IT WAS VERIFIED THAT CONSTRUCTION FAILED WITH THE LOOSE LOCKING SCREWS. ALMOST ALL PEDICLE SCREWS REMAINED ON PLACE. NON UNION WAS ALSO NOTED. THE PATIENT UNDERWENT REVISION SURGERY, WHICH WENT WELL.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21180076 ↗
• InjuryMar 27, 2023Migration; Migration

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2022. IN THE SURGERY, T2/3 WAS FIXED WITH SYMPHONY PRODUCTS, T5-S2 WERE FIXED WITH EXPEDIUM VERSE PRODUCTS. L1-S2 WERE CONNECTED BY STRIKER¿S OPENDOMINO PRODUCTS. ONLY THE SET SCREWS ON THE LEFT SIDE OF T2/3 HAVE COME OFF THIS MONTH. ON (B)(6) 2023, SYMPHONY SCREWS IN T2/3 WERE REMOVED AND REPLACED WITH EXPEDIUM VERSE PRODUCTS, AND THE AFFECTED AREA WERE RE-FIXED IN THE REVISION SURGERY. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SET SCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16624395 ↗
• InjuryMar 27, 2023Migration; Migration

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2022. IN THE SURGERY, T2/3 WAS FIXED WITH SYMPHONY PRODUCTS, T5-S2 WERE FIXED WITH EXPEDIUM VERSE PRODUCTS. L1-S2 WERE CONNECTED BY STRIKER¿S OPENDOMINO PRODUCTS. ONLY THE SET SCREWS ON THE LEFT SIDE OF T2/3 HAVE COME OFF THIS MONTH. ON (B)(6) 2023, SYMPHONY SCREWS IN T2/3 WERE REMOVED AND REPLACED WITH EXPEDIUM VERSE PRODUCTS, AND THE AFFECTED AREA WERE RE-FIXED IN THE REVISION SURGERY. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SET SCREW. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16624337 ↗
• InjuryJul 5, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A PRIMARY POSTERIOR FUSION (C2-T1) FOR TREATING ATHETOID CEREBRAL PALSY. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. APPROXIMATELY 8 MONTHS AFTER THE INITIAL PROCEDURE, THE SCREWHEAD ON THE SETSCREW (T1 LEFT) HAD COME OFF A ROD. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE SURGEON MADE THE FOLLOWING COMMENTS: THE PATIENT¿S DAILY ACTIVITIES CHARACTERIZED BY THE CEREBRAL PALSY MIGHT HAVE TRIGGERED THE SCREWHEAD TO COME OFF A ROD. AS MENTIONED ON THE ABOVE, ONLY THE SCREWHEAD HAD COME OFF. ON THE OTHER HAND, HE USED A TORQUE DRIVER TO CHECK IF THE SETSCREW ITSELF HAD BEEN TIGHTENED IN THE LESION, AND IT WAS CONFIRMED THAT THE SETSCREW HAD BEEN SECURED. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14916600 ↗